Comparison of Intravitreal Ranibizumab and Macular Grid-pattern Laser for Treatment of Diabetic Macular Edema

University of Szeged (SZTE)

Status

Unknown

Conditions

Macular Edema

Treatments

Drug: ranibizumab

Radiation: macular grid-pattern laser

Study type

Observational

Funder types

Other

Identifiers

NCT00994799

CRFB002AHU04T

CRFB002DHU06T

Details and patient eligibility

About

This study investigates the hypothesis that ranibizumab injection given into the eye is an efficacious and safe treatment option applied for swelling of the macula (site of sharp vision) in diabetes.

Full description

This is a randomized, controlled, three-center trial to assess the efficacy and safety of intravitreal ranibizumab injections in diabetic macular edema. Comparator arm consists of patients receiving macular grid-pattern laser therapy.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female type I or II diabetic patients over 18 years of age
Diagnosis of DME secondary to diabetic retinopathy and decrease in vision is due to DME and not due to other causes in the opinion of the investigator
Patients who have a BCVA score between 78 and 39 letters in the study eye using ETDRS-like visual acuity charts at a testing distance of 4 meters
Expectation by the investigator that patient will potentially benefit from laser treatment or ranibizumab treatment
Willing and able to comply with all study procedures

Exclusion criteria

Active intraocular inflammation, any active infection or history of uveitis
Uncontrolled glaucoma or neovascularization of the iris in the study eye
Structural damage within 0.5 disc diameter of the center of the macula in the study eye likely to preclude improvement in visual acuity following the resolution of macular edema, including atrophy of the retinal pigment epithelium, subretinal fibrosis, laser scar(s), epiretinal membrane involving fovea or organized hard exudate plaques
Concurrent disease in the study eye that could compromise visual acuity or prevent the improvement of visual acuity (including diabetic proliferative retinopathy) or require medical or surgical intervention during the study period, including cataract, retinal vascular occlusion, retinal detachment, macular hole or choroidal neovascularization of any cause
Panretinal laser photocoagulation in the study eye within 6 months prior to or during the study or focal/grid laser photocoagulation in the study eye within 3 months prior to study entry
Treatment with anti-angiogenic drugs (pegaptanib sodium, anecortave acetate, bevacizumab, ranibizumab, etc) or intravitreal corticosteroids in the study eye within 3 months prior to randomization
Any intraocular surgery in the study eye within 3 months prior to randomization
History of vitrectomy in the study eye
Ocular conditions in the study eye that require chronic concomitant therapy with topical ocular or systemically administered corticosteroids
Pregnancy and lactation